Acute Spinal Cord InjuryNCT06030531
Spasticity and Functional Recovery After SCI
An observational study of Acute Spinal Cord Injury and Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
Spasticity is one of the most common symptoms manifested in humans with spinal cord injury (SCI). However, the neural mechanisms underlying the development of spasticity over time after an acute SCI are not yet understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Spinal Cord Injury, Spinal Cord Injuries
- What is being tested?
- Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammation and Analysis of biomarkers
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prospective participants who meet the study inclusion criteria will be identified by bi-weekly chart review ofall new admissions to the acute inpatient spinal cord injury unit at the Shirley Ryan AbilityLab (SRAlab).Eligible patients will be invited to participate by the clinical staff during their first week of admission. Prospective participants that meet the inclusion criteria for the Control group will be recruited using various sources including the Shirley Ryan AbilityLab non-patient research database, participants who have taken part in our earlier studies, word of mouth, people who work at or visit our center and are interested in research participation.
Who may be able to join
- Male and females 18 years of age or greater
- Basic proficiency in English language communication
- Are admitted to the Shirley Ryan AbilityLab as a spinal cord injury patient
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) level above L2
- American Spinal Cord Injury Association Impairment Scale (AIS) grades A, B, C, or D
- Patients with SCI within the first week of inpatient admission to the Shirley Ryan AbilityLab after sustaining a SC
- Male and females 18 years of age or greater
- Basic proficiency in English language communication
Who cannot join
- Under 18 years of age
- Severe cognitive impairment that precludes the ability to participate in a comprehensive physical exam or give verbal consent
- ISNCSCI level below L2
- People who have sustained SCI >30 days
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
- Any debilitating disease prior to the SCI that caused exercise intolerance
Show all 21Show fewer
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
- History of seizures or epilepsy
- Ongoing cord compression or a syrinx in the spinal cord or people who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk 13. Metal plate in skull
- Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
- Skull fractures, skull deficits or concussion within the last 6 months
- Presence of orthoses and presence of spinal precautions or healing incisions that make the area inaccessible to the testing procedures. This criterion will be applied as needed for the specific study procedures that may need to access the areas under restriction.
- Formal diagnosis of Post-Traumatic Stress Disorder (PTSD)
- Individuals in the control group:
- Under 18 years of age
- Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease
- History of neurological impairment or conditions affecting the Central Nervous System
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spasticity and Functional Recovery in Humans With Acute to Subacute Spinal Cord Injury.
Spasticity is one of the most common symptoms manifested in humans with spinal cord injury (SCI). However, the neural mechanisms underlying the development of spasticity over time after an acute SCI are not yet understood. Using electrophysiological and imaging techniques along with traditional measurements of neurological recovery in the acute rehabilitation setting including physical exam and functional assessments; the investigators aim to examine the relationship between development of spasticity, residual descending motor pathways and functional and neurological recovery in humans with SCI from acute to subacute phase
Read the detailed description
The purpose of this study is to measure changes to motor-evoked potentials (MEPs) and to evaluate if the development of spasticity is related to residual descending motor pathways and to a better neurological recovery and functional improvement in individuals with SCI from the acute to the subacute phase. The investigators will also test for the presence of biological markers in the blood that may correlate with levels of spasticity or neurological recovery and functional improvement, including the presence or absence of neuroplastic genetic polymorphisms (e.g. BDNF Val66Met polymorphism), as well as circulating levels of neuroplastic (e.g. BDNF) or inflammatory factors (e.g. interleukins, TNF) that may affect neuronal growth and functional restoration.
- Conditions
- Acute Spinal Cord Injury, Spinal Cord Injuries
- Being tested
- Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammation, Analysis of biomarkers
- Keywords
- Spasticity, Recovery, Bio-markers
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammationOther
We will test for presence of biological markers in blood that may correlate with levels of spasticity or neurological recovery and functional improvement, including the presence or absence of neuroplastic genetic polymorphisms (e.g. BDNF Val66Met polymorphism), as well as circulating levels of neuroplastic(e.g. BDNF) or inflammatory factors (e.g. interleukins, TNF) that may affect neuronal growth and functional restoration.
Analysis of biomarkersOther
We will test for the presence of biological markers in the blood to compare the distribution of polymorphisms and biomarkers with the spinal cord injury patient population.
| Study group | Role | What they receive |
|---|---|---|
| Inpatients | Prospective participants who meet the study inclusion criteria will be identified by bi-weekly chart review of all new admissions to the acute inpatient spinal cord injury unit at the Shirley Ryan AbilityLab (SRAlab).
Eligible patients will be invited to participate by the clinical staff during their first week of admission. Receives: Other: Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammation; Other: Analysis of biomarkers | |
| Control group | We will enroll non-injured healthy individuals to compare the level of biomarkers Receives: Other: Analysis of biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth scale (MAS)
This clinical scale will be used by measuring resistance encountered during manual passive muscle stretching using a six-point ordinal scale (0=no increase in tone, 1/+1=slight increase in tone with a catch and release or minimal resistance at the end or less than half of the range of movement, respectively, 2=more marked increased tone through most of the range of movement but affected parts easily moved, 3=considerable increase in tone and passive movement difficultly, and 4=affected parts rigid)
Measured: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Motor evoked potential (MEP)
Transcranial magnetic stimulation will be delivered and the coil will be positioned over the vertex and moved around this point to determine the optimal position for eliciting a motor evoked potentials (MEPs) in legs muscles.
Measured: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
First swing test (FST)
We will use the pendulum test to measure muscle tone at the knee by using gravity to provoke muscle stretch reflexes during passive swinging of the lower limb.
Measured: From the time of admission to the hospital and enrolled in the study till the time of the discharge (up to 12 weeks)
Secondary outcomes (2)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
At the time of the admission, after obtaining consent, and at the time of discharge, the chart will be reviewed to obtain the ISNCSCI score
Measured: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Circulating biomarkers of inflammation and neuroplasticity
In this study, we will focus on tracking expression of key inflammatory cytokines that have been shown to play a pivotal role in activating the major nuclear factor kappa-B (NF-κB) inflammatory pathway. Specifically, we will characterize serum levels of pro-inflammatory cytokines interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor (TNF-α) and anti-inflammatory marker interleukin-10 (IL-10). We will also measure levels of circulating neuroplasticity marker Brain-derived neurotrophic factor (BDNF)
Measured: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Jul 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Perez, Shirley Ryan AbilityLab
- Investigators
- Monica A Perez, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030531
- Sponsor's protocol ID
- STU00210582
- Status last verified
- Sep 2023
- First submitted
- 7 Apr 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spasticity and Functional Recovery in Humans With Acute to Subacute Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT06030531
- Acronym / sponsor ID
- STU00210582
- Conditions
- Acute Spinal Cord Injury, Spinal Cord Injuries
- Keywords
- Spasticity, Recovery, Bio-markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spasticity is one of the most common symptoms manifested in humans with spinal cord injury (SCI). However, the neural mechanisms underlying the development of spasticity over time after an acute SCI are not yet understood. Using electrophysiological and imaging techniques along with traditional measurements of neurological recovery in the acute rehabilitation setting including physical exam and functional assessments; the investigators aim to examine the relationship between development of spasticity, residual descending motor pathways and functional and neurological recovery in humans with SCI from acute to subacute phase
Detailed description
The purpose of this study is to measure changes to motor-evoked potentials (MEPs) and to evaluate if the development of spasticity is related to residual descending motor pathways and to a better neurological recovery and functional improvement in individuals with SCI from the acute to the subacute phase. The investigators will also test for the presence of biological markers in the blood that may correlate with levels of spasticity or neurological recovery and functional improvement, including the presence or absence of neuroplastic genetic polymorphisms (e.g. BDNF Val66Met polymorphism), as well as circulating levels of neuroplastic (e.g. BDNF) or inflammatory factors (e.g. interleukins, TNF) that may affect neuronal growth and functional restoration.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatients | – | Other: Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammation, Other: Analysis of biomarkersProspective participants who meet the study inclusion criteria will be identified by bi-weekly chart review of all new admissions to the acute inpatient spinal cord injury unit at the Shirley Ryan AbilityLab (SRAlab). Eligible patients will be invited to participate by the clinical staff during their first week of admission. |
| Control group | – | Other: Analysis of biomarkersWe will enroll non-injured healthy individuals to compare the level of biomarkers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective participants who meet the study inclusion criteria will be identified by bi-weekly chart review ofall new admissions to the acute inpatient spinal cord injury unit at the Shirley Ryan AbilityLab (SRAlab).Eligible patients will be invited to participate by the clinical staff during their first week of admission. Prospective participants that meet the inclusion criteria for the Control group will be recruited using various sources including the Shirley Ryan AbilityLab non-patient research database, participants who have taken part in our earlier studies, word of mouth, people who work at or visit our center and are interested in research participation.
Key inclusion criteria (8 listed)
- Male and females 18 years of age or greater
- Basic proficiency in English language communication
- Are admitted to the Shirley Ryan AbilityLab as a spinal cord injury patient
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) level above L2
- American Spinal Cord Injury Association Impairment Scale (AIS) grades A, B, C, or D
Key exclusion criteria (21 listed)
- Under 18 years of age
- Severe cognitive impairment that precludes the ability to participate in a comprehensive physical exam or give verbal consent
- ISNCSCI level below L2
- People who have sustained SCI >30 days
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measures of spasticity, connectivity and analysis of single nucleotide polymorphisms and biomarkers of inflammationWe will test for presence of biological markers in blood that may correlate with levels of spasticity or neurological recovery and functional improvement, including the presence or absence of neuroplastic genetic polymorphisms (e.g. BDNF Val66Met polymorphism), as well as circulating levels of neuroplastic(e.g. BDNF) or inflammatory factors (e.g. interleukins, TNF) that may affect neuronal growth and functional restoration. | Other | Inpatients |
| Analysis of biomarkersWe will test for the presence of biological markers in the blood to compare the distribution of polymorphisms and biomarkers with the spinal cord injury patient population. | Other | Control group, Inpatients |
Primary outcome
Modified Ashworth scale (MAS)
Time frame: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
This clinical scale will be used by measuring resistance encountered during manual passive muscle stretching using a six-point ordinal scale (0=no increase in tone, 1/+1=slight increase in tone with a catch and release or minimal resistance at the end or less than half of the range of movement, respectively, 2=more marked increased tone through most of the range of movement but affected parts easily moved, 3=considerable increase in tone and passive movement difficultly, and 4=affected parts rigid)
Motor evoked potential (MEP)
Time frame: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Transcranial magnetic stimulation will be delivered and the coil will be positioned over the vertex and moved around this point to determine the optimal position for eliciting a motor evoked potentials (MEPs) in legs muscles.
First swing test (FST)
Time frame: From the time of admission to the hospital and enrolled in the study till the time of the discharge (up to 12 weeks)
We will use the pendulum test to measure muscle tone at the knee by using gravity to provoke muscle stretch reflexes during passive swinging of the lower limb.
2 secondary outcomes
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Circulating biomarkers of inflammation and neuroplasticity
Time frame: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica A Perez, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Spinal Cord Injury and Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth scale (MAS) (time frame: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.